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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFLUOREX (TM) 600 (FLURSILFOCON A)
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantG.T. Laboratories, Inc.
111 # Wabash Ave.
Chicago, IL 60602
PMA NumberP880001
Supplement NumberS016
Date Received06/19/1989
Decision Date07/20/1990
Product Code HQD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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